Cleared Traditional

K802087 - BABYBIRD 2 VENTILATOR

K802087 is an FDA 510(k) clearance for BABYBIRD 2 VENTILATOR, manufactured by Bird Products Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K802087 · Bird Products Corp. · Anesthesiology device
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Oct 1980
Decision
31d
Days
Class 2
Risk

K802087 is an FDA 510(k) clearance for the BABYBIRD 2 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Bird Products Corp. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bird Products Corp. devices

FDA 510(k) Submission Details - K802087

510(k) Number K802087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1980
Decision Date October 03, 1980
Days to Decision 31 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 140d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K802087.
SIEMENS-ELEMA AB SERVO VENTILATOR 900 C
K811102 · Siemens Elema AB · May 1981
DRAGER AV2 ANESTHESIA VENTILATOR
K802168 · Draeger Medical, Inc. · Dec 1980
INFANT VENTILATOR, (RESPIRATOR) PLAN B
K802583 · Healthdyne, Inc. · Dec 1980
MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM
K800650 · Hospal Medical Corp. · Apr 1980
SIEMENS-ELEMA AB MANUAL VENTILATION
K800114 · Siemens Elema AB · Mar 1980
VENTILATOR, INFANT MODEL 100
K781926 · Healthdyne, Inc. · Dec 1978